CTRI/2018/06/014480Not yet recruitingPhase 4
A Multicentric, Randomized, Double Blind, Placebo Controlled Trial to assess the Efficacy and Safety of Saccharomyces Boulardii CNCM-I 3799 Bacillus Subtilis CU – 1 combination For treatment of Acute Diarrhoea in Indian Children
Alkem Laboratories Limited6 sites in 1 country180 target enrollmentStarted: June 20, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 6
- Primary Endpoint
- Duration of diarrhea will be computed as time in hours after study product administration to the last abnormal (loose or liquid) stool preceding a normal stool output and the same would also be computed during the study period. Stool frequency will be noted as number of times the subject passes stool every day. Stool consistency will be evaluated on a 4 point Likert scale: 1- normal, 2- Loose, 3- semi-solid, 4 – liquid.
Study Overview
Brief Summary
The proposed clinical trial is to assess the efficacy of the probiotic saccharromyces boulardii in combination with the bacteria bacillus subtilis in reducing the duration and frequency of acute diarrhoea in children in the age group of 5 month to 6 years. The study is double arm, placebo controlled randomized prospective study. The study proposes to enroll a totral of 180 subjects from 4 sites and follow up the enrolled subjects 3 months post treatment period to assess the incidence of acute diarrhoea. The safety profile of the probiotic will also be assessed in terms of AEs.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Double Blind Double Dummy
Eligibility Criteria
- Ages
- 6.00 Month(s) to 5.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Subjects aged between 6 months.
- •5 years of either gender presenting with acute diarrhea of ≤ 72 hours duration without history of intake of any antibiotic and without dehydration or with features of mild or moderate dehydration. 2.Parent or legal guardian of the subjects /subject must give written informed consent for study participation. 3.Parent of the subjects must follow all instructions as per the protocol.
Exclusion Criteria
- •1.Subjects with clinical signs of dysentery, severe dehydration requiring hospitalization or parenteral fluid therapy.
- •2.Intake of any systemic antibiotic or any anti-diarrheal medication, in the previous 3 weeks prior to screening 3.Subjects who are debilitated or seriously ill or immunocompromised.
- •4.Subjects with symptoms or suspicion of an organic lesion of the digestive tract, or with undiagnosed abdominal pain or rectal bleeding or other GI disorder especially ulcerative colitis, Crohn’s disease, history of carcinomas of the bowel, malabsorption syndrome, intolerance to certain food types (lactose), functional diarrhea and functional constipation.
- •5.Use of probiotics in the last 3 weeks prior to baseline visit.
- •6.Current use of any drugs or treatments which is supposed to decrease the gastrointestinal motility or any other concomitant anti-diarrheal medication.
- •7.Subjects who have undergone ileostomy, jejunostomy or colostomy 8.Subjects with hypersensitivity to any ingredient in the formulation.
- •9.Subjects with coexisting features of acute systemic disease like septicemia, meningitis, pneumonia etc.
Outcomes
Primary Outcomes
Duration of diarrhea will be computed as time in hours after study product administration to the last abnormal (loose or liquid) stool preceding a normal stool output and the same would also be computed during the study period. Stool frequency will be noted as number of times the subject passes stool every day. Stool consistency will be evaluated on a 4 point Likert scale: 1- normal, 2- Loose, 3- semi-solid, 4 – liquid.
Time Frame: 5 days
Secondary Outcomes
- The assessment of the safety of the study medications will be evaluated by monitoring of both serious (SAE) and non-serious solicited and unsolicited adverse events during the study period. Assessment of tolerability will be done by the physician on a 4 point Likert Scale 1- excellent, 2- good, 3- fair, 4- poor.(5 days)
- Subjects in both groups will be followed up 3 months post intervention to compare the incidence of acute diarrheal episodes between the test and placebo group.(3 months)
Investigators
Study Sites (6)
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